Cover Photo Courtesy of
Sotax

This article discusses the recent increase in FDA warning letters citing cGMP violations related to excipients and describes USP’s analysis of the excipient-related warning letters issued from 2013 through 2018. It also explains how USP’s programs and resources can help drug companies comply with FDA regulations.

This article discusses the current and potential future impacts of the application of Industry 4.0 concepts to the pharmaceutical manufacturing industry.

Increasingly, pharmaceutical production plants must be efficient and user friendly. They must also meet industry demand for shorter development times with minimal active pharmaceutical ingredient (API) usage and direct transfer from development to production without scale-up, as well as flexible batch sizes and integrated quality monitoring. This article discusses how continuous manufacturing technologies can help drug product manufacturers meet these requirements.

This article describes the batch-to-batch variation of a multiyear excipient production data set and the subsequent impact of the variation observed on the excipient’s processability and/or functionality. This type of consistency data can help drug product manufacturers assess the risks associated with using specific grades of excipients and/or vendors for their products.

Extractable and leachable (E&L) testing determines whether unwanted and potentially harmful compounds are pulled out of a product’s packaging, delivery system, or manufacturing surface under certain conditions (extractables) or passively migrate into a product over time (leachables). As part of the US FDA guidelines, all drug products in development must be submitted to the FDA for approval, which includes a review of E&L testing.

This article is based on the master thesis “Investigation of the influence of functional excipients for tablet cores on the quality of applied coatings,” by Martin Wewers under the direction of Dr. Jan Henrik Finke at the Technical University of Braunschweig, in Germany. The study was conducted at the university’s Institute for Particle Technology (iPAT) and at JRS Pharma, in Rosenberg, Germany.

This article discusses how focusing on quality throughout every stage of development and manufacturing not only creates a high-quality capsule product, but also improves manufacturing processes and the bottom line.

PharmSci 360, the annual meeting of the American Association of Pharmaceutical Scientists (AAPS), will take place November 3-6 at the Henry B. Gonzalez Convention Center in San Antonio, TX. More
than 6,000 scientists and other pharmaceutical professionals are expected to attend as well as hundreds of pharmaceutical manufacturers, CDMOs, and R&D exhibitors. The annual trade show and conference presents numerous networking and learning opportunities for attendees.

This edition of “Eye on excipients” discusses the pros and cons of direct-compression tableting and describes a study conducted to test the benefits of adding dry binders to direct-compression tablet formulations.

CPhI Worldwide, a trade show focused on APIs, excipients, and ingredients, takes place November 5-7 in Frankfurt, Germany. Co-located with ICSE (contract research, development, and manufacturing),
InnoPack (packaging), P-Mec (pharmaceutical machinery), FDF (finished dosage formulation), and BioProduction (biopharmaceuticals), the exposition will host more than 2,500 exhibitors. Last year’s event was attended by 45,000 pharmaceutical professionals representing various sectors of the pharmaceutical industry and more than 150 countries.